Janssen’s HIV-1 Pill Symtuza Gains Approval from FDA

FDA Approval

HIV patients have some good news this morning. The U.S. Food and Drug Administration (FDA) approved Janssen Pharmaceutical’s Symtuza, the first and only complete darunavir-based single-tablet regimen (STR) for the treatment of human immunodeficiency virus type 1 (HIV-1).

The FDA awarded approval based on Phase III results that showed Symtuza was highly effective and well-tolerated in treating antiretroviral-naïve HIV-1 patients through 48 weeks. Trial data showed that up to 95 percent of participating patients achieved or maintained virologic suppression. Symtuza, Janssen said, combines the proven high barrier to resistance of darunavir with a formulation designed for improved tolerability and the convenience of a single tablet regimen. While the FDA approved the medicine, it does come with a Boxed Warning regarding the risk of post-treatment acute exacerbation of hepatitis B.

Joseph Eron, head of the University of North Carolina’s Center for AIDS Research, said Symtuza was successful in Phase II trials in treating not only those HIV patients beginning therapy but those who were stably suppressed on antiretroviral (ARV) therapy, including patients with more complex treatment histories or previous virologic failure. Eron said that demonstrated the efficacy of Symtuza as an important new option for a wide variety of patients.

Brian Woodfall, head of late development and infectious diseases at Janssen, said the company has spent more than 25 years developing transformational medicines for HIV care. The FDA’s approval of Symtuza “marks another important milestone” in the company’s mission to address those medical needs, he said.

“There is more to be done in our fight to make HIV history, and we will not stop here. We will continue our efforts to advance treatment and remain steadfast in our pursuit of fulfilling the dream of a preventive HIV vaccine,” Woodfall said in a statement.

Symtuza has also been approved by the European Commission (EC) and Health Canada for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older with a body weight of at least 40 kg.

The FDA’s approval of Symtuza provides HIV patients with another tool. In the first half of this year, the FDA approved several new drugs to treat HIV and the new head of the U.S. Centers for Disease Control and Prevention predicted the AIDs epidemic can be defeated within the next three to seven years. Data from CDC shows there were an estimated 37,600 new HIV infections in the United States in 2014, the most recent year for which the agency provides data. HIV drugs approved this year include Gilead Sciences Biktarvy, a triple combination treatment of bictegravir and emtricitabine/tenofovir alafenamide and Theratechnologies’ Trogarzo (ibalizumab), the first HIV-1 inhibitor for patients with multi-drug resistant HIV-1. In March Mylan also snagged approval for its HIV treatment Symfi.

Janssen’s Symtuza will be offered alongside its own Juluca, which was approved last year. Juluca was co-developed with GlaxoSmithKline’s subsidiary ViiV Healthcare. Juluca combines ViiV’s dolutegravir, an integrase strand transfer inhibitor and Janssen’s rilpivirine, a non-nucleoside reverse transcriptase inhibitor.

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